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To Investigate the Effect of 2019 Novel Coronavirus Infection on the Condition of Patients With Hyperthyroidism

Effect of COVID-19 Infection on Thyroid Function and Psychological Status in Patients With Hyperthyroidism-one-year Intervention and Follow-up

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06204393
Enrollment
120
Registered
2024-01-12
Start date
2023-01-07
Completion date
2024-08-07
Last updated
2024-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Graves Disease

Brief summary

The goal of this observational study is to learn about the correlation between COVID-19 and hyperthyroidism in Patients with hyperthyroidism complicated with COVID-19. The main questions it aims to answer are: * The main research object is Graves disease (GD) patients. * Changes of hyperthyroidism in GD patients complicated with COVID-19 * Changes of anxiety and depression in GD patients before and after SARS-CoV-2 infection. * The effect of psychological intervention in GD patients after COVID-19. Participants will have regular follow-upfor one year to hyperthyroidism in our hospital, and the investigators will collect the thyroid function and related examination indexes of patients in the corresponding time period.

Detailed description

Longitudinal analysis of GD status was performed: Three follow-up time points were identified: before COVID-19, three months and one year after recovering from COVID-19 (the first follow-up visit, the second follow-up visit. Main collection items: Hyperthyroidism symptoms, signs, hyperthyroidism complications, psychological evaluation results, other complications,blood routine, liver and kidney function, thyroid function (FT3, FT4, TSH), thyroid-related antibodies, glucose and lipid metabolism (FBG, HbA1c, TC, TG, HDL-C, LDL-C), thyroid ultrasound and hyperthyroidism medication.Through this to understand the changes of hyperthyroidism in HT patients complicated with COVID-19 and the changes of anxiety and depression in hyperthyroidism patients before and after SARS-CoV-2 infection.And the effect of psychological intervention in GD patients after COVID-19.

Interventions

OTHERThyroid metabolic index

The following indicators were collected from these patients: hyperthyroidism symptoms, signs, hyperthyroidism complications, psychological evaluation results, other complications,blood routine, liver and kidney function, thyroid function (FT3, FT4, TSH), thyroid-related antibodies, glucose and lipid metabolism (FBG, HbA1c, TC, TG, HDL-C, LDL-C), thyroid ultrasound and hyperthyroidism medication. Psychological evaluations (using the 7-item Generalized Anxiety Disorder Questionnaire, GAD-7, and the Patient Health Questionnaire 9, PHQ-9) and interventions.

Sponsors

Qilu Hospital of Shandong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. According to the diagnostic criteria of hyperthyroidism in the Chinese Guidelines for the Diagnosis and Treatment of Thyroid Diseases formulated by the Chinese Society of Endocrinology of the Chinese Medical Association, the patient had been diagnosed with hyperthyroidism. 2. In accordance with the diagnostic criteria of The diagnosis and Treatment Protocol for novel coronavirus Infection (Trial version 10).

Exclusion criteria

1. Cases with incomplete data 2. Patients with severe autoimmune diseases, hematological diseases and malignant tumors 3. Immunodeficiency (e.g.AIDS, long-term use of corticosteroids or other immunosuppressive drugs leading to immunodeficiency) 4. Follow-up was less than 30 days 5. The results of thyroid function were less than 3 times

Design outcomes

Primary

MeasureTime frameDescription
Serum TPO-Ab were measured with chemiluminescence method.Up to 9 monthsTPO-Ab in IU/ml
Serum TTG-Ab were measured with chemiluminescence method.Up to 9 monthsTG-Ab in IU/ml
Serum TSH were measured with chemiluminescence method.Up to 9 monthsTSH in µIU/mL
Serum FT4 were measured with chemiluminescence method.Up to 9 monthsFT4 in pmmol/L
Serum FT3were measured with chemiluminescence method.Up to 9 monthsFT3 in pmmol/L
Serum TRAb were measured with chemiluminescence method.Up to 9 monthsTRAb in IU/L
Assess the changes of patients' psychological state with Generalized Anxiety Disorder-7 Items Scale(GAD-7)Up to 9 monthsEvaluation of anxiety state by GAD-7 scale. The lowest score of DAD-7 is 0, and the highest score is 21. The higher the score, the heavier the anxiety.
Assess the changes of patients' psychological state with Patient Health Questionnaire-9(PHQ-9)Up to 9 monthsEvaluation of depression by PHQ-9 scale. The lowest score of PHQ-9 is 0, and the highest score is 27. The higher the score, the heavier the depression.

Countries

China

Contacts

Primary ContactKuanxiao Tang, M.D.
tangkx_ql@hotmail.com18560082261

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026